RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving a vaccine with Montanide ISA-51 and sargramostim may cause a stronger immune response and kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with Montanide ISA-51 and sargramostim in treating patients with stage IV breast cancer.

Cohorts of 5-8 patients receive escalating doses of telomerase: 540-548 peptide and CMV 495 peptide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 or 2 of 8 patients experience dose-limiting toxicity. A total of 12 patients receive treatment at the MTD.

Patients are followed within 30 days and then at 6 and 12 months.

PROJECTED ACCRUAL: A total of 5-28 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of stage IV breast cancer

Failed at least 1 prior conventional therapy for metastatic disease

Measurable or evaluable disease by clinical, radiographic, or laboratory assessment

Measurable lesions must be at least 1 dimension

At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

The following are not considered measurable:

Pleural effusion

Bone lesions

Tumor markers

HLA-A2-expressing disease by human leukocyte antigen typing

No CNS metastases by contrast CT scan and/or MRI

No brain metastases within the past 4 years

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Not specified

Menopausal status

Not specified

Performance status

ECOG 0-1

Life expectancy

More than 6 months

Hematopoietic

WBC ≥ 3,000/mm^3

Platelet count ≥ 75,000/mm^3

Hemoglobin ≥ 10 g/dL

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)

ALT and AST ≤ 2.5 times ULN

Hepatitis B negative

Hepatitis C negative

Renal

Creatinine ≤ 1.5 times ULN

Immunologic

HIV negative

Human T-cell lymphotrophic virus-1 negative

No active infection

No major autoimmune disorder that would preclude study participation

Other

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception during and for 6 months after study participation

No alcohol abuse or illicit drug use within the past 12 months

No clinically significant comorbid disease or other underlying condition that would preclude study participation

No significant psychiatric disorder that would preclude giving informed consent or complying with study

More than 30 days since initiation of prior immunotherapy (e.g., trastuzumab [Herceptin])

Concurrent immunotherapy (e.g., trastuzumab) allowed provided regimen was initiated more than 30 days before study entry, disease is stable or progressive, and patient plans to continue immunotherapy for the duration of study participation

No other concurrent hematopoietic growth factors

Chemotherapy

More than 30 days since prior chemotherapy

No concurrent chemotherapy

Endocrine therapy

More than 30 days since prior glucocorticoids

More than 30 days since initiation of prior hormonal therapy (e.g., tamoxifen, anastrozole, or letrozole)

Concurrent hormonal therapy (e.g., tamoxifen, anastrozole, or letrozole) allowed provided regimen was initiated more than 30 days before study entry, disease is stable or progressive, and patient plans to continue hormonal therapy for the duration of study participation

No concurrent glucocorticoids

Radiotherapy

More than 30 days since prior radiotherapy

No concurrent radiotherapy

Surgery

Not specified

Other

More than 14 days since prior anticoagulants (e.g., warfarin, heparin, or enoxaparin)

Low-dose anticoagulants to maintain IV catheter patency allowed

More than 30 days since prior immunosuppressive drugs

More than 30 days since prior experimental therapy

No concurrent immunosuppressive drugs

No other concurrent investigational products

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079157